UVM to Examine Potential New Parkinson’s Disease Treatment as Part of National Study
Release Date: 03-22-2007
The University of Vermont will participate in a large-scale national clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinson's disease (PD). While creatine is not an approved therapy for PD or any other condition, it is widely thought to improve exercise performance. The potential benefit of creatine for PD was identified by Parkinson’s researchers through a new rapid method for screening potential compounds. The trial, which begins today, is sponsored by the National Institutes of Health (NIH).
PD is a degenerative disorder of the brain in which patients develop symptoms, including progressive tremor, slowness of movements, and stiffness of muscles, resulting from the loss of dopamine, a neurotransmitter that helps control movement. It affects at least one million people in the United States. Although certain drugs that increase the level of dopamine in the brain can reduce the symptoms of PD, there are no proven treatments that can slow the progressive deterioration in function.
Creatine is marketed as a nutritional supplement. Studies have suggested that it can improve the function of mitochondria, which produce energy inside cells. It also may act as an antioxidant that prevents damage from compounds that are harmful to cells in the brain. In a research model of PD, creatine has been shown to prevent loss of the cells that are typically affected.
The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. UVM/Fletcher Allen is one of 51 medical centers in the United States and Canada that will be recruiting patients as part of an effort to enroll 1720 people with early-stage PD.
“This study is an important step,” says Elias A. Zerhouni, M.D., director of the NIH. “We are pleased to have so many sites participating in this study, which may help us move more quickly toward developing a therapy that could change the course of this devastating disease. The goal is to improve the quality of life for people with Parkinson's for a longer period of time than is possible with existing therapies.”
The trial is the first large study in a series of NIH-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's Disease). UVM has been affiliated with the program since 2002. The NIH has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process ¯ from laboratory research to pilot studies in a select group of patients to the definitive phase III trial of effectiveness in people with PD.
“This study is an example of our commitment to Parkinson’s research,” said Story C. Landis, Ph.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), the NIH institute leading the study. “We are trying to explore every possible option for reducing the burden of this disease.”
According to UVM primary investigator Robert Hamill, M.D., professor and chair of neurology, “The team involved in our movement disorder program is very committed to bringing new and novel therapies to citizens of Vermont and upstate New York who have Parkinson's disease and being part of this NIH consortium is an important step forward in this regard. A number of Vermonters participated in the initial pilot studies that were conducted at our NIH-sponsored site here at UVM, which helped to provide some of the initial data that suggested creatine’s potential as an effective therapy to alter the course of PD.”
The study will enroll people who have been diagnosed with PD within the past five years and who have been treated for two years or less with levodopa or other drugs that increase the levels of dopamine in the brain. Half of the participants will receive creatine and half will receive a placebo. Neither the participants nor their doctors will know which treatment they receive. The investigators will measure disease progression using standard rating scales that measure quality of life, ability to walk, cognitive function, and the ability to carry out other activities of daily living. Avicena Group, Inc. will provide the creatine and the placebo for the study.
In addition to Hamill, the UVM-based project team also includes James Boyd, M.D., assistant professor of neurology and study co-investigator; Shannon Lenox, clinical research coordinator in neurology; and Jeanette Baker, R.N., movement disorder nurse in neurology.
To find out more about participating in this study at UVM, call 1-802-656-3876. General study information can also be obtained by calling 1-800-352-9424, emailing email@example.com, or visiting Parkinson's Trial.
The NINDS is a component of the NIH within the Department of Health and Human Services and is the nation’s primary supporter of biomedical research on the brain and nervous system. The National Institutes of Health — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.